Actively Recruiting

Age: 18Years - 80Years
All Genders
NCT04265040

DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies

Led by University Hospital Heidelberg · Updated on 2023-11-30

2040

Participants Needed

1

Research Sites

380 weeks

Total Duration

On this page

Sponsors

U

University Hospital Heidelberg

Lead Sponsor

U

University Medicine Greifswald

Collaborating Sponsor

AI-Summary

What this Trial Is About

The DZHK TranslatiOnal Registry for CardiomyopatHies (DZHK TORCH) represents a unique resource of clinical data and high quality biological samples to enable innovative clinical and molecular studies on cardiomyopathies (CMP). As a multi-center German cardiomyopathy registry, TORCH has been prospectively admitting patients since December 2014. 2,300 patients were recruited as planned. Taken together, patient data showed that the prevalence of these diseases is much higher in men than in women, atrial fibrillation is common in all forms of CMPs as well as rare forms of disease indicate a higher risk and higher morbidity. This DZHK TORCH register is now to be expanded with a second phase (DZHK TORCH-Plus). The second phase DZHK TORCH-Plus consists of 4 main modules: 1. "Clinical phenotyping, follow-up \& biosampling" 2. "Genomics", 3. "Inflammation" and 4. "Biomarker". The central aims are 1) to significantly increase the number of probands (n = 4340) in order to better address the different types of CMPs, especially patients with rare CMP forms such as LVNC and ARVC or with probably molecularly explainable cardiomyopathies (familial DCM), 2) to prolong the longitudinal with a further follow-up to achieve sufficient events and thereby derive clinical recommendations for risk assessment, 3) to increase the number of probands with state-of-the-art phenotyping, 4) to pinpoint the effect of myocardial inflammation, fibrosis, gender and to determine or predict genotypes based for outcome, 5) to validate novel biomarkers developed in other DZHK studies, and 6) to foster active cooperation with international CMP registries and partners from industry.

CONDITIONS

Official Title

DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Non-ischemic structural cardiomyopathies
  • Age between 18 and 80 years
  • Ability to understand and sign the consent form
  • At least one of the following diagnoses: Dilated Cardiomyopathy (family/genetic, inflammatory/persistent myocarditis, idiopathic, left sided systolic dysfunction with ejection fraction  45%), Left ventricular hypertrophy (sarcomere hypertrophic cardiomyopathy, amyloidosis), Left ventricular non-compaction cardiomyopathy, Arrhythmogenic right ventricular cardiomyopathy
Not Eligible

You will not qualify if you...

  • Age below 18 years or above 80 years
  • Uncontrollable arterial hypertension
  • Primary pulmonary arterial hypertension
  • Radiation therapy in the chest area
  • Drug or alcohol addiction
  • Life expectancy less than 1 year due to non-cardiological conditions
  • Significant heart valve disease
  • Ischemic diseases or severe congenital heart diseases (including VSD, Fallot tetralogy, Ebstein anomaly)
  • Chemotoxic cardiomyopathy
  • Condition after myocarditis
  • Combination of multiple traditional risk factors (e.g., hypertension and diabetes mellitus)
  • Advanced chronic non-cardiac disease (e.g., chronic hepatitis or HIV)
  • Tachymyopathy

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Heidelberg - Clinic of Cardiology, Angiology and Pneumology

Heidelberg, Baden-Wurttemberg, Germany, 69120

Actively Recruiting

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Research Team

F

Farbod Sedaghat-Hamendani, Dr.

CONTACT

J

Johannes Trebing, Dr.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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DZHK TORCH-Plus is a Registry for Patients With Cardiomyopathies and Serves as Source for Cardiovascular Research Studies | DecenTrialz